Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00386516
Status:
WITHDRAWN
Last Update Posted:
2017-08-01
First Post:
2006-10-10
Brief Title:
Study to Test the Benefit and Safety of GM-CT-01 in Combination With 5-FU to Treat Bile Duct and Gall Bladder Cancer
Sponsor:
Galectin Therapeutics Inc
Organization:
Galectin Therapeutics Inc
Study Overview
Official Title:
Phase 2 Multi-center Open-label Trial to Evaluate Efficacy and Safety of GM-CT-01 in Combination With 5-FU as First Line Chemotherapy in Patients With Advanced Biliary Cancer
Status:
WITHDRAWN
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Financing and re-organization
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this clinical trial is to determine whether the combination of the established chemotherapeutic agent 5-fluorouracil5-FU and the large carbohydrate molecule GM-CT-01 is beneficial in treating advanced gall bladder and bile duct cancer
Detailed Description:
Determine the overall response rate ORR defined as complete response CRrate plus partial response PR rate using Response Evaluation Criteria in Solid Tumors RECIST as well as the stable disease SD rate in subjects with unresectable locally advanced or metastatic cholangiocarcinoma or other biliary tract tumors treated with GM-CT-01 plus 5-Fluorouracil DAVFU at doses of 280 mgm2 and 600 mgm2 respectively during cycles of 4 consecutive days of treatment followed by a 24-day follow-up period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None